Gene therapy analytics and CMC

CELL AND GENE THERAPY INSIGHTS

July 2024

Gene therapy analytics and CMC

Innovator Insight

Quantitative analysis of lipids and nucleic acids in lipid nanoparticles using monolithic column

Quantitative analysis of lipids and nucleic acids in lipid nanoparticles using monolithic column

N Pavlin, M Bavčar, T Kovačič et al.

Overcoming challenges in gene therapy analytics

Overcoming challenges in gene therapy analytics

Anthony J Blaszczyk, Ana Carreras González

Regulatory perspective

Clinical trial applications for investigational medicinal products that contain or consist of genetically modified organisms: industry experiences under the European Union Clinical Trial Regulation (536/2014)

Clinical trial applications for investigational medicinal products that contain or consist of genetically modified organisms: industry experiences under the European Union Clinical Trial Regulation (536/2014)

S Beattie, N Lambot, J Awigena-Cook et al.

FastFacts

Accelerating process analytics: leveraging dPCR to quantitate AAV viral titers

Accelerating process analytics: leveraging dPCR to quantitate AAV viral titers

Interview

Exploring analytical assays and CMC challenges for viral vector-based therapies

Exploring analytical assays and CMC challenges for viral vector-based therapies

Vladimir Slepushkin

Advancing the analytical toolkit to drive viral gene delivery

Advancing the analytical toolkit to drive viral gene delivery

Chelsea Amstuz, Itzcoatl Pla

Navigating gene therapy QC: exploring the expanding AAV vector analytical toolkit

Navigating gene therapy QC: exploring the expanding AAV vector analytical toolkit

Conference Insight

Global perspectives for cellular and gene therapy development and regulatory expectations: a conference report from the 2023 NIFDS-PMDA-USP Workshop for Advanced Therapies

Global perspectives for cellular and gene therapy development and regulatory expectations: a conference report from the 2023 NIFDS-PMDA-USP Workshop for Advanced Therapies

B Clarke, M Kim, Y Sato et al.

Webinars

Quadplex dPCR as a tool to analyze genome integrity and heterogeneity in gene therapy drug products

Quadplex dPCR as a tool to analyze genome integrity and heterogeneity in gene therapy drug products

Ryan Massopust

Control your AAV titers with in-line UV-Vis analysis and PAT-Driven UF/DF systems

Control your AAV titers with in-line UV-Vis analysis and PAT-Driven UF/DF systems

Brandon Goldberg

Leveraging dPCR for residual DNA and viral titer quantitation in advanced therapy manufacture

Leveraging dPCR for residual DNA and viral titer quantitation in advanced therapy manufacture